Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock.

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00000552
First received: October 27, 1999
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

To test if early revascularization, primarily with angioplasty (PTCA) or bypass surgery (CABG), reduced all-cause in-hospital mortality from cardiogenic shock compared to conventional treatment, including thrombolysis.


Condition Intervention Phase
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Shock, Cardiogenic
Procedure: angioplasty, transluminal, percutaneous coronary
Procedure: coronary artery bypass
Drug: thrombolytic therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

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Further study details as provided by New England Research Institutes:

Study Start Date: September 1994
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Approximately 7.5 percent of all acute myocardial infarctions which are diagnosed in an emergency room or in-hospital lead to cardiogenic shock and an in-hospital death rate of 70 to 80 percent, usually within one to two days of diagnosis of cardiogenic shock. The high death rate has not changed in the last two decades. Non-random clinical series and animal studies suggest that rapid revascularization following cardiogenic shock complicating acute myocardial infarction may substantially improve survival. However, the apparent benefit reported in the non-random clinic studies could have resulted partly from a selection bias towards patients with a better prognosis.

DESIGN NARRATIVE:

Randomized, multicenter, Phase III, controlled clinical trial. Patients with shock due to left ventricular failure complicating myocardial infarction were randomly assigned to emergency revascularization or initial medical stabilization. Revascularization was accomplished by either coronary-artery bypass grafting or angioplasty. A total of 152 patients were randomized to early revascularization and 150 patients to conventional therapy consisting of thrombolytics and a possible late attempt at revascularization. Intraaortic balloon counterpulsation was performed in 86 percent of the patients in both groups. The primary endpoint was mortality from all causes at 30 days. Secondary endpoints included all-cause mortality at six months and assessment of the quality of life in survivors after discharge.

All patients with a clinically suspected diagnosis of cardiogenic shock complicating myocardial infarction formed a registry, with limited information collected on in-hospital procedures, medications, length of stay and vital status at discharge.

The study has been extended through June, 2005 for patient follow-up and data analyses. Long-term survival rates (6 to 11 years post-MI) will be estimated and the quality of life of survivors of acute MI complicated by cardiogenic shock will be studied. Extended trial data analyses will be conducted: a) To determine the early echocardiographic parameters which are associated with one year survival in cardiogenic shock patients, and to assess the interaction of these parameters with early revascularization; b) To examine differences in disease course and patient outcome as a function of age, gender, national practice, and changes in serial hemodynamic measurements, as well as to better characterize the related conditions and complications of cardiogenic shock.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women with myocardial infarction and cardiogenic shock.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000552

Sponsors and Collaborators
New England Research Institutes
Investigators
Investigator: Lynn Sleeper New England Research Institute, Inc.
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000552     History of Changes
Other Study ID Numbers: 96, R01HL049970
Study First Received: October 27, 1999
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Cardiovascular Diseases
Infarction
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 30, 2014